Intended Use; Indications For Use; Environmental Conditions - Otto Bock 4R104-60 Instructions For Use Manual

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  • ENGLISH, page 9
1.1 Construction and Function
The 4R104=60 and 4R104=75 double adapters, sliding, are used to connect
2 pyramid adapters. The pyramid receivers make it possible to make distal
and proximal angle adjustments of the prosthetic components in the frontal
and sagittal planes. The dovetail guide makes it possible to shift the pros­
thetic components in the frontal and sagittal planes.
1.2 Combination possibilities
This prosthetic component is part of the Ottobock modular system and can
be combined with other components of this modular system. Any restrictions
regarding the combination possibilities are listed in this section. Contact the
manufacturer with questions.

2 Intended use

2.1 Indications for use

The product is to be used solely for lower limb prosthetic fittings.
2.2 Area of application
Approved for a body weight of up to 100 kg.

2.3 Environmental conditions

Allowable environmental conditions
Temperature range for use: -10 °C to +60°C
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions
Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e.g. talcum)
2.4 Service Life
In general, all modular adapters are tested by the manufacturer for 3 million
load cycles. Depending on the patient's level of activity, this corresponds to
a service life of 3 to 5 years.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible risks of accident or injury.
CAUTION
9

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4r104-75

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